The present invention relates to an intraocular lens packaging system with an optional additive reservoir and a method of making and using the same. More particularly, the present invention relates to a packaging system that may be used to store an intraocular lens and optionally an additive material, such as a lubricant, until use during an ophthalmic surgical procedure at which time the packaging system may be used as an intraocular lens inserter.
The natural crystalline lens of the eye plays a primary role in focusing light onto the retina for proper vision. However, vision through the natural lens may become impaired due to an injury or the formation of a cataract caused by aging or disease. To restore vision in the case of a cataractous lens, the natural lens is typically removed and replaced with an artificial lens. Implantation of an artificial lens may also be useful to make a refractive correction in an eye without the removal of a non-cataractous natural crystalline lens.
Many surgical procedures have been developed for removing the natural lens if cataractous. Typically, a slender implement is inserted through a small incision in the eye to contact the natural lens. The implement includes a cutting edge that is ultrasonically vibrated to emulsify the lens. The emulsified fragments of the lens are then aspirated out of the eye through a passage located in the proximity of the cutting edge. The slender nature of the implement enables extraction of the lens through a small incision in the eye. Removal of the natural lens through a relatively small incision is preferred over other procedures requiring larger incisions. Procedures requiring a relatively smaller incision can lessen the trauma and complications experienced both during surgery and postoperatively.
Because the incision required to remove a natural lens is relatively small, artificial intraocular lenses that do not require any enlargement of the surgical incision for implantation are preferred. Intraocular lenses commonly include a generally disk shaped optic which focuses light on the retina and at least one outwardly extending haptic portion for proper positioning and support of the optic within the eye. Flexible intraocular lenses enable a lens to be folded and compressed so as to occupy a smaller cross-sectional area for passage of the lens through a relatively small surgical incision in an aphakic eye, wherein the natural lens has been removed, or a phakic eye, wherein the natural lens has not been removed. Once inserted through the narrow incision, the intraocular lens is permitted to expand to its original size and shape.
A number of devices have been developed to insert a flexible intraocular lens through a relatively small incision in a phakic or aphakic eye. For example, in U.S. Pat. No. 4,681,102 a hinged cartridge which closes about a lens to fold the lens into a narrower configuration is disclosed. The cartridge is placed into an inserter mechanism that advances the folded lens into the eye. The inserter, however, requires several components to be manipulated and assembled to accomplish the folding and implantation procedure. Rheinish et al. disclose in U.S. Pat. No. 5,275,604, a device whereby a lens is pushed through a narrowing lumen formed with spiraling grooves to fold a lens into a smaller size as it is moved toward an eye for implantation therein. The manufacture of spiraling grooves in a tapering lumen is difficult if not impossible to accomplish in a practical manner. In U.S. Pat. No. 5,304,182, Rheinish et al. disclose a device whereby a curling member is shifted laterally to fold a lens into a size small enough to pass through a narrow incision. However, no locking arrangement is provided to ensure complete closing of the curling member which may cause complications.
Moreover, while the devices disclosed in the noted patents function to reduce the cross-sectional size of a lens for insertion into an eye, each requires opposing side edges of the lens to be folded over on themselves in order to fit through a narrow incision. As a result, the lens must unfold within the eye to regain its original shape and size. Such unfolding requires the lens, and particularly the haptic, to be swung in an arc, thus risking damage to the interior of the eye. Additionally, the folding and pressing of the lens required to pass the lens through a small incision places a significant amount of inward pressure on the lens. As a result, the lens is frequently discharged from the inserter with considerable force and velocity. This forceful, uncontrolled release of the lens within the eye also places the interior of the eye at risk of being injured.
Further, many known inserters do not maintain control of the orientation of the lens as the lens is advanced into the eye. Consequently, the lens may rotate or turn about a longitudinal axis as it is pushed through the inserter. Most lenses, however, are made to be set within the eye in a specific orientation. Accordingly, such turning of the lens can result in the lens being placed in the eye with improper orientation.
In addition to the difficulties noted above associated with using known intraocular lens inserters, difficulties also arise with regard to properly loading the intraocular lens within the inserter. If an intraocular lens is loaded within an inserter improperly, the lens could possibly be implanted within the eye with improper orientation or the lens could be damaged or destroyed. Often times, if not always, when loading an intraocular lens within an inserter, a viscoelastic or similar lubricating material is necessary to avoid damage to the lens as the lens is forced through the inserter. A viscoelastic or lubricating material is loaded within the inserter upon loading the lens to ease insertion and lessen the possibility of lens damage. However, the additional step of loading a viscoelastic or lubricating material at the time of loading the intraocular lens is at times cumbersome and inconvenient.
Accordingly, a long felt need exists for a simple, reliable, cost effective and convenient device and method of using the same to implant an intraocular lens within an eye while minimizing potential injury to the eye.
The present invention pertains to an intraocular lens packaging system with an optional additive material reservoir, and a method of making and using the same to implant an intraocular lens (IOL) within an eye in a simple, reliable, cost effective and convenient manner. The packaging system of the present invention in its preferred construction provides a non-permanently sealed additive material reservoir for packaging an additive material such as a viscoelastic material, a lubricant, an anti-inflammatory agent, an antibiotic or a combination thereof and a non-permanently sealed IOL compression chamber for packaging a loaded, properly oriented IOL. In using the subject packaging system, both the IOL compression chamber seal and the optional additive material reservoir seal, which are preferably one in the same, are removed. Upon removal of the seal(s), additive material is discharged from the additive material reservoir into the IOL compression chamber just prior to compression of the IOL. Upon compression, the IOL is laterally compressed into a smaller cross-sectional configuration for insertion through a relatively small incision in the eye. Since the side edges of the lens are not folded over on themselves during lateral compression, the IOL does not swing open within the eye in order to regain its original shape. As a result, the risk of a part of the IOL striking and injuring an interior portion of the eye after release of the lens from the inserter is reduced.
Accordingly, it is an object of the present invention to provide a packaging system for an intraocular lens that may be used as an inserter.
Another object of the present invention is to provide a packaging system for both an additive material and an intraocular lens.
Another object of the present invention is to provide a packaging system for both an additive material and an intraocular lens that may be used as an inserter.
Another object of the present invention is to provide a packaging system that may be used to implant an intraocular lens within an eye with reduced risk of injuring internal portions of the eye.
Another object of the present invention is to provide a packaging system that is relatively simple and convenient to use in a surgical procedure.
Still another object of the present invention is to provide an additive material and intraocular lens packaging system that is reliable and cost effective.
These and other objectives and advantages of the present invention, some of which are specifically described and others that are not, will become apparent from the detailed description, examples and claims that follow.